A Culturally Adapted Positive Health Programme - Moving on After Breast Cancer Plus- for Breast Cancer Survivors: A Feasibility Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 354
- 试验地点
- 2
- 主要终点
- Patient Health Questionnaire-9 (PHQ-9)
研究概览
简要总结
Breast cancer (BC) ranks second among all the types of cancer and is equally common in developing as well as developed countries. Breast cancer is most common type of cancer worldwide and its diagnosis as well as early treatment is associated with distress. The aim of this study is to explore the feasibility of integrating a 'Moving on After Breast Cancer (ABC)' manual developed by service user (Dr A Saleem) with Cognitive Behavior Therapyfor Pakistani women who are breast cancer (BC) survivors attending primary care and oncology services in Pakistan B) refine the Moving on ABC plus so as to develop a culturally appropriate therapeutic programme to be tested in a future definitive randomized controlled trial.
详细描述
According to an estimate of World Health Organization (2000) cancer was responsible for 12% of all the deaths from all causes worldwide and rate of cancer is expected to increase 50% by the year 2020. In Pakistan every ninth women has a chance of developing breast cancer, which is highest rate in Asia. The estimated incidence rate of breast cancer in Pakistan is 50/100,000. Despite the high association of distress with breast cancer, data on prevalence of depression in women with breast cancer especially in low income countries is limited .
The proposed project consists of two phases: 1) Phase 1: Integration of the two existing interventions Moving On ABC and the Cognitive Behavior Therapy and the refinement of the integrated intervention. 2) Phase 2: Randomized Control Trial (RCT). Sample size of Phase II will be comprised of 50 patients. Patients will be divided into two groups. One group will receive Group moving on ABC Plus intervention and other group will receive routine care. The total sample size of the effectiveness trial 354.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast cancer (stage I to stage IV)
- •Has completed primary treatment for breast cancer
- •Score of 10 or above on PHQ - 9 or GAD - 7
- •Age 18 and above
排除标准
- •Already diagnosed with any psychiatric illness
- •Already taking psychiatric medicines
- •Severe cognitive impairment (not able to give consent to take part in intervention)
结局指标
主要结局
Patient Health Questionnaire-9 (PHQ-9)
时间窗: Changes from baseline to 4th and 6th month outcome
Patient Health Questionnaire-9 (PHQ-9) will be used to diagnose depression.Minimum score of PHQ-9 is 0 and maximum score is 27. This scale categorizes depression in 5 different categories: minimal depression (score range 1-4), Mild depression (5-9), Moderate depression (10-14), Moderately severe depression (15-19), and Sever depression (20-27).
次要结局
- Intrusive Thoughts Scale(Changes from baseline to 4th and 6th month outcome)
- Generalized Anxiety Disorder - 7(Changes from baseline to 4th and 6th month outcome)
- The Functional Assessment of Cancer Therapy - Breast (FACT-B)(Changes from baseline to 4th and 6th month outcome)
- EuroQol-5D (EQ-5D)(Changes from baseline to 4th and 6th month outcome)
- Client Satisfaction Questionnaire(This will be administered at 4-month follow up)
- Multidimensional Scale for Perceived Social Support (MSPSS)(Changes from baseline to 4th and 6th month outcome)
- Rosenberg Self Esteem Scale(Changes from baseline to 4th and 6th month outcome)